What Ablative Solutions does

Ablative Solutions, Inc. is a privately-held medical device company founded in 2011 that develops the Peregrine System for catheter-based renal denervation as a treatment for uncontrolled hypertension. The company's core technology is a percutaneous infusion catheter featuring three microneedles that deliver dehydrated alcohol directly into the perivascular space of the renal arteries to interrupt overactive sympathetic nerve signaling, achieving deep radial and circumferential denervation. The microneedles remain retracted within radiopaque guide tubes during placement, enabling fluoroscopic confirmation and three-point wall apposition prior to therapy delivery.

The product portfolio consists of two offerings: the Peregrine System Infusion Catheter, which has 510(k) clearance for perivascular infusion of diagnostic and therapeutic agents, and the Peregrine System Kit, an investigational combination product co-packaging the catheter with dehydrated alcohol for renal denervation. The Peregrine catheter received CE Mark approval in Europe in 2015, while in the United States the company is advancing the Phase 2 TARGET BP I trial under an FDA IND allowance granted in 2016 across approximately 20 global centers. The procedure is performed using standard PCI/PTA workflows with comparable procedure times, mild sedation, and no capital equipment requirements.

Ablative Solutions generates revenue, in principle, through hardware sales of the Peregrine System Kit to hospitals and catheterization labs, but is effectively pre-commercial today: the kit is limited to investigational use in the United States and European activity is positioned through a post-market clinical study. The company is venture-backed, with cumulative disclosed funding exceeding $250 million across multiple rounds led by BioStar Capital, Gilde Healthcare, Invus Opportunities, and Michigan Accelerator Fund I. Headquarters are in Kalamazoo, Michigan, with an additional office in San Jose, California, and the company operates with 11-50 employees.

Name

Ablative Solutions

Legal name

Ablative Solutions, Inc.

Website

https://ablativesolutions.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Ablative Solutions is a clinical-stage medical device company developing the Peregrine System, a catheter-based renal denervation technology that uses three microneedles to deliver dehydrated alcohol to treat uncontrolled hypertension. The company serves interventional cardiology centers in Europe (CE Mark) and is conducting Phase 2 trials in the United States.

Ownership category

akta.pro rank

Product category

Interventional Cardiology Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Hypertension & Ambulatory Blood Pressure Care (HLAKABAH)

Keywords

• Renal denervation devices
• Hypertension treatment
• Catheter-based devices
• Perivascular infusion
• Medical device manufacturing

Headquarters

HQ city

Wakefield

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Medical Device Sales: The company generates revenue through the sale of its Peregrine System Infusion Catheter and related Kits (co-packaged Peregrine Catheter and Dehydrated alcohol) to hospitals and clinical facilities conducting renal denervation procedures.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Ablative Solutions develops and manufactures the Peregrine System, a catheter-based medical device for renal denervation procedures to treat uncontrolled hypertension. The system features three microneedles that deliver dehydrated alcohol into the perivascular space to interrupt overactive sympathetic nerve activity influencing blood pressure. The product portfolio consists of the 510(k) cleared Peregrine System Infusion Catheter and the investigational Peregrine System Kit (catheter co-packaged with dehydrated alcohol).

Product overview

Ablative Solutions offers catheter-based medical devices for the treatment of hypertension. The core product portfolio consists of the Peregrine System™ Infusion Catheter (FDA 510(k) cleared) and the Peregrine System™ Kit (investigational combination product). The catheter features proprietary three-microneedle technology for targeted perivascular delivery of neurolytic agents to achieve renal denervation, targeting overactive sympathetic nerves that contribute to hypertension.

Differentiator

Problem solved

Functional benefit

Products and services

• Peregrine System Infusion Catheter A catheter-based device with three microneedles for percutaneous delivery of diagnostic and therapeutic agents into the perivascular space of peripheral blood vessels. The catheter has 510(k) clearance for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature. Intended for use by interventional cardiologists and vascular specialists in hospital catheterization laboratories.
• Peregrine System Kit An investigational combination product consisting of the Peregrine Catheter co-packaged with dehydrated alcohol for catheter-based renal denervation to treat uncontrolled hypertension. Currently limited to investigational use in clinical trials in the United States. Targeted at patients with uncontrolled hypertension who do not achieve adequate blood pressure control with medication.

Quantifiable outcome

• Over 50% of patients with hypertension have uncontrolled blood pressure despite medication therapy, representing a significant unmet clinical need

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Medtronic: Medtronic's Symplicity Spyral renal denervation system is the most advanced commercially-available RDN platform and a direct competitor to Ablative Solutions' Peregrine System in treating uncontrolled hypertension via catheter-based sympathetic nerve ablation.
• ReCor Medical (Otsuka): ReCor's Paradise ultrasound renal denervation system directly competes with Peregrine in the same RDN category; acquired by Otsuka Pharmaceutical in 2022, it is pursuing US approval for hypertension with a different energy-based mechanism.

Emerging players

• SoniVie: SoniVie is developing the Tivus intravascular ultrasound RDN system, representing an emerging player in renal denervation with overlapping clinical focus on resistant hypertension and a comparable percutaneous, catheter-based delivery model.
• CVRx: CVRx developed the Barostim neo neuromodulation device for heart failure and resistant hypertension, representing an emerging neuromodulation approach to the same uncontrolled hypertension patient segment targeted by Ablative Solutions.
• Vascular Dynamics: Vascular Dynamics developed the MobiusHD implant for hypertension treatment, an alternative catheter-delivered neuromodulation approach targeting resistant hypertension with overlapping patient population and clinical goal.
• Mercator MedSystems: Mercator's Bullfrog and Cricket microinfusion catheters deliver therapeutic agents directly into the vessel wall, sharing the perivascular/local drug-delivery concept underlying the Peregrine System.

Broad incumbents

• Johnson & Johnson (Biosense Webster / J&J MedTech): J&J's cardiovascular division is the historical commercializer of the Fischell-designed drug-eluting stent platform and a broad incumbent in interventional cardiology, with strategic interest in RDN technology via its Biosense Webster electrophysiology franchise.
• Terumo: Terumo is a global interventional device incumbent with extensive catheter manufacturing and cardiovascular distribution capabilities, making it a comparable broad strategic in the percutaneous interventional space and a potential acquirer.
• Boston Scientific: Boston Scientific previously developed the Vessix renal denervation system and remains a broad incumbent in interventional cardiovascular devices; it is highly likely to be either an acquirer or direct competitor in any RDN market that develops.
• Abbott: Abbott is a leading interventional cardiology incumbent with extensive catheter-based device infrastructure, deep hospital relationships, and renal denervation optionality, making it a potential strategic acquirer or competitive threat to Ablative Solutions.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/ablatvsolutions

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds10 records

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Ablative Solutions